Sleep Quality and Biomarkers in Adolescent Girls With Anorexia Nervosa

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Conditions studied: Anorexia Nervosa

In brief

The purpose of this observational study is to systematically evaluate how a 12-month multimodal psychiatric treatment program affects sleep quality, inflammatory and hormonal biomarkers, eating disorder psychopathology, and health-related quality of life in adolescent girls (aged 10-18 years) diagnosed with anorexia nervosa. The main questions it aims to answer are: * Do adolescent girls with anorexia nervosa have measurable changes in sleep patterns (total sleep time, sleep efficiency, REM sleep, deep sleep) compared to age- and sex-matched published values, and do these improve after 12 months of psychiatric treatment? * Are specific body markers (like NLR, CRP, vitamin D, and lipid profile) linked to how severe sleep problems, eating disorder symptoms, and treatment results are in this group? * To assess these outcomes, researchers will compare participants' baseline measurements to their own 12-month follow-up measurements to determine whether multimodal psychiatric treatment produces clinically meaningful improvements in sleep architecture, biomarker profiles, psychopathology, psychological flexibility, and quality of life. Participants will: * Take-home sleep recordings with a wireless device (NOX A1) in their usual environment at the start and after 12 months of treatment. * Complete validated self-report questionnaires assessing sleep quality (PSQI), daytime sleepiness (ESS-CHAD for children and adolescents), eating disorder symptoms (EDE-Q), depression, anxiety, and stress (DASS-21), psychological flexibility (AFQ-Y8), and health-related quality of life (KIDSCREEN-52) at baseline and 12-month follow-up. * Give blood samples at the start and after 12 months for testing of inflammation markers, hormone levels, lipids, and anthropometric measurements. * Take part in a Day Hospital Program at the Department of Psychiatry, University Hospital of Split (KBC Split), Croatia, which includes Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, individual counselling, family work, and medication if needed.

Key facts

Study ID: NCT07644728
Run by: University of Split, School of Medicine
People needed: 25
Starts: 2026-05-30
Expected to finish: 2029-12-31
Last updated by the study team: 2026-06-12

Who can join

Age: 10 and older, up to 18. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Female sex assigned at birth
Age between 10 and 18 years (inclusive) at the time of study enrollment
First-time diagnosis of anorexia nervosa according to ICD-10 criteria at the time of enrollment, including:
Anorexia nervosa (F50.0)
Atypical anorexia nervosa (F50.1)
Eating disorder, unspecified (F50.9) with predominant restrictive or anorexic presentation
Currently under the care of a child and adolescent psychiatrist at the Department of Psychiatry, University Hospital of Split (KBC Split), Croatia
Enrolled in or eligible for the Day Hospital Program for Children and Adolescents at the Department of Psychiatry, KBC Split
Ability to read and understand Croatian language sufficiently to complete self-report questionnaires
Parent or legal guardian willing and able to provide written informed consent prior to any study procedure
Participant willing and able to provide written assent prior to any study procedure
Participant and parent/guardian willing to undergo all study procedures at both time points, including:
Home polysomnography (NOX A1) at baseline and 12-month follow-up
Completion of all self-report questionnaires at baseline and 12-month follow-up
Fasting blood sampling at baseline and 12-month follow-up

You may not qualify if…

Age younger than 10 years or older than 18 years at the time of enrollment
Male sex assigned at birth
Previous diagnosis of anorexia nervosa prior to current enrollment (i.e., recurrent or relapsing AN - this study enrolls first-diagnosis cases only)
Anorexia nervosa currently in clinical remission at the time of enrollment
Comorbid psychiatric diagnosis of any of the following:
Intellectual disability (any severity, ICD-10: F70-F79)
Autism spectrum disorder (ICD-10: F84)
Schizophrenia spectrum or other psychotic disorder (ICD-10: F20-F29)
Bipolar affective disorder, any type (ICD-10: F31)
Substance use disorder, any substance (ICD-10: F10-F19)
Severe or chronic somatic illness documented in medical history, including but not limited to:
Central nervous system disorders (epilepsy, acquired brain injury, neurodegenerative disease, ICD-10: G00-G99)
Chronic inflammatory or autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis)
Primary endocrine disorder independent of AN (e.g., primary hypothyroidism, type 1 or type 2 diabetes mellitus, congenital adrenal hyperplasia)
Active or history of malignancy
Chronic renal or hepatic disease
Use of any medication known to significantly alter sleep architecture or inflammatory biomarker levels that was initiated prior to study enrollment and is unrelated to the study treatment program, including:
Benzodiazepines or z-drugs (zopiclone, zolpidem)
Antipsychotic medications
Systemic corticosteroids
Immunosuppressive agents
Melatonin or melatonin receptor agonists Medications initiated as part of the Day Hospital treatment program after enrollment will be documented and included as covariates in statistical analyses and do not constitute an exclusion criterion.
Presence of an active somatic condition at the time of enrollment requiring acute inpatient medical treatment (e.g., severe electrolyte imbalance requiring intravenous correction, acute cardiac arrhythmia) that would preclude safe participation in the Day Hospital Program
Physical or cognitive inability to cooperate with home polysomnography device placement or self-report questionnaire completion, as judged by the treating child and adolescent psychiatrist
Simultaneous participation in another interventional clinical trial that could influence sleep parameters, nutritional status, inflammatory markers, or psychiatric outcomes.

Full record on ClinicalTrials.gov

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